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News
The FDA has approved remibrutinib (Rhapsido) — an oral BTK inhibitor — as the first treatment specifically approved for symptomatic dermographism (SD), a condition where everyday friction triggers intensely itchy hives. Already approved for chronic spontaneous urticaria, the drug showed significantly better outcomes than placebo in the phase 3 RemIND trial. Experts warn that insurance coverage — not just FDA approval — will be the biggest hurdle for patients.
The FDA has approved remibrutinib (Rhapsido), an oral Bruton tyrosine kinase inhibitor (BTKi), for adults with symptomatic dermographism (SD) — a form of chronic hives triggered by skin friction or scratching — that isn't adequately controlled by H1 antihistamines. This marks the first FDA-approved treatment specifically for SD, a condition that affects more than 90% of adults with chronic hives, with over half experiencing persistent symptoms despite antihistamine use.
The approval was backed by the phase 3 RemIND trial, which showed remibrutinib significantly outperformed placebo, with some patients seeing improvement as early as 2 weeks. The drug was previously approved for chronic spontaneous urticaria (CSU) in September 2025 and is also approved in the EU, UK, and China for that indication.
By the Numbers:
Why it matters: While this approval gives clinicians a much-needed evidence-based option for SD, experts caution that access could be a major barrier — FDA approval doesn't guarantee insurance coverage. Clinicians will need to carefully document diagnosis and prior treatment history, and be mindful of the drug's safety profile, including bleeding risk.
